Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus

Summary

This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.

Eligibility

Key Inclusion Criteria

1. Participant's age at the time of signing the informed consent:

   * United States: 18 to 75 years (inclusive)
2. Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening
3. Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg/day) for at least 3 months prior to screening
4. BMI ≥25 kg/m² and ≤50 kg/m²
5. Body weight change \<5% over the past 3 months prior to screening
6. Capable of giving signed informed consent and willing to comply with all protocol procedures

Key Exclusion Criteria

1. Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening
2. Poor glycemic control (fasting plasma glucose \>270 mg/dL)
3. History of diabetic ketoacidosis or severe hypoglycemia within 6 months
4. Clinically significant cardiovascular disease (e.g., NYHA class III/IV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)
5. History of pancreatitis or factors increasing the risk of pancreatitis
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2
7. Clinically significant liver disease, renal impairment (eGFR \<60 mL/min/1.73 m²), or abnormal laboratory findings at screening
8. Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening

Conditions3

Interventions2

Locations13 sites

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